The Current Landscape of Amplification

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Kory Murphy
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1 The Current Landscape of Amplification President s Council of Advisors in Science and Technology (PCAST): National Academies of Science, Engineering and Technology (NASEM): s.aspx Food and Drug Administration (FDA): Federal Trade Commission (FTC): Hearing Aids: FDA Regulated, Class I Devices o o o Changes to above from December 7, 2016: idance/guidancedocuments/ucm pdf o Hearing Aids Currently Available Over the Counter: Audicus: Embrace: HiHealth Innovations: IHear: Listen Clear: MD Hearing: Sound World Solutions: Mail Order Entities EBay Personal Sound Amplification Products:

2 FDA Draft Guidance: edocuments/ucm pdf (labeling requirements; no manufacturing standards) o o o Personal Sound Amplification Products Currently Available Over the Counter: Able Planet: Amplifiers.html Bean: dance/guidancedocuments/ucm pdf Eargo: Otofonix: 977Hi9Ov8pkBEiQA5B_ipV4Fde6K-q55QQCygObj2rAtr- NVLoB1_hyIpOcyFsIaAmzH8P8HAQ Phantom: PocketTalker: Sound World Solutions: ProSounds H2P: Thousands of options available through traditional and online retailers. o Personal Sound Amplification Products Currently Available from a Provider: Amp: dance/guidancedocuments/ucm pdf Plaid: Hearable/Warable: A consumer electronic products where amplification of speech is one of its features/functions. o No FDA regulations. o o o o Currently Available (pre-order): HerePlus: Nuheara IQ Ear:

3 Applications: Available on mobile phones. No FDA regulations. EarMachine: EarSpy: Enhanced Ears: Hearing Aid Pro HearingOS: Jacoti: Petralex: Super Hearing Aid

4 Froedtert Hospital Center for Advanced Care, 5th floor 9200 W. Wisconsin Ave. Milwaukee, WI Hearing aid fitting options Previous hearing aid users only: 1 hour appointment to program the aids to the most recent audiogram (hearing evaluation), make adjustments based on patient s subjective feedback, verification of hearing aid setting via electroacoustic analysis or in situ using real ear measurements and discuss and review with patient use of the specific device. Fee: $100. Further follow up visits will be scheduled at patient request and be billed at standard rate ($50/monaural, $80/binaural). New hearing aid users and previous hearing aid users: hour appointment to program the aids to the most recent audiogram (hearing evaluation), make adjustments based on patient s subjective feedback, verification of hearing aid setting via electroacoustic analysis or in situ using real ear measurements and discuss and review with patient use of device and device features. This appointment will also include review of components, features, and function of the hearing aid(s); maintenance practices, telephone use; and adjustment of volume/programs as appropriate. Review basic hearing aid care and use including battery changes, insertion and removal of hearing aid, maintenance and cleaning. Supervised hands-on practice provided for these skills as needed. Audiologist will counsel about benefits and limitations of hearing aids and effective communication strategies. Audiologist will also discuss with patient their specific communication hearing needs and, based on device options, hearing aid features will be activated and reviewed with patient based on those needs. Speech in noise testing will be completed with and without the hearing aid to verify benefit. A new hearing aid kit will be provided which includes: batteries, battery tester, sanitizer spray, storage cases, cleaning tools, handouts. Fee: $625 dispensing fee (for both monaural and binaural fittings) Follow up visit(s) will be scheduled in 2-4 weeks from fitting and is included. Follow up service will include verification and validation of fitting (if not completed at the fitting appointment). Further adjustments at audiologist s determination based on patient feedback, experience with the hearing aid, and other measures. Service warranty for 6-months post fitting. Previous users New/Previous users Appointment time 1 hour hours Program aid Yes Yes Adjustments/fine tuning Yes Yes Verification Yes Yes Review device components, features & Not included Yes function Care, use and maintenance Not included Yes Supervised hands-on practice Not included Yes Counseled re: hearing aid Not included Yes benefits/limitations Discuss effective communication Not included Yes strategies New hearing aid kit Not included Yes Patient specific communication needs Not included Yes assessment Speech in noise testing Not included Yes Fee $100 $625 Follow up Not included Yes (2-4 weeks post fit) Service warranty Not included Yes (6 months post fit)

5 Hearing and Communica on Ques onnaire Name: Date: Our goal is to op mize your ability to hear so you can more easily communicate with others. To reach this goal, it is important that we understand your communica on needs, personal preferences, and expecta ons. We can then use our exper se to recommend the hearing system that is most appropriate for you. Please complete the following ques ons. Be as honest and as precise as possible. Thank you. 1. Please list the top 2 3 situa ons where you would like to hear be er. Be as specific as possible. 2. How well do you think a hearing system will improve your hearing? Mark X on the line. I expect them to: Not be helpful at all 1 10 Greatly improve my hearing 3. How mo vated are you to use hearing aids if they are recommended? Mark an X on the line. Not mo vated at all 1 10 Greatly mo vate 4. What is your most important considera on regarding hearing aids? Rank order the following factors with 1 as the most important and 4 as the least important. Hearing aid size and the ability of others Improved ability to understand speech in not to see the hearing aids noisy situa ons (eg. restaurants, par es) Improved ability to hear & understand Cost of the hearing system speech 5. Do you think you prefer hearing devices that (check one): are totally automa c, you don't need allows you to adjust volume and change to make any adjustments listening programs 6. On a scale of 1 to 10, 1 being the worst and 10 being the best, rate your communica on ability? 7. There is a range of hearing aid technologies and the cost depends on the sophis ca on of the circuitry. Please check the cost category that represents the maximum amount you are willing to spend. It is helpful for us to know your budget so that we can provide you with the most appropriate hearing aids. Economy digital hearing aids: $1400 per aid Standard digital hearing aids: $1900 per aid Advanced digital hearing aids: $2500 per aid Premium digital hearing aids: $3400 per aid

Comments in Response to the April 18 Workshop: Now Hear This: Competition, Innovation, and Consumer Protection Issues in Hearing Health Care

Federal Trade Commission Office of the Secretary 600 Pennsylvania Avenue Washington, DC 20580 RE: Comments in Response to the April 18 Workshop: Now Hear This: Competition, Innovation, and Consumer Protection